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Serving leading biopharmaceutical companies globally:

Dow
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018485

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NDA 018485 describes ISOPTIN, which is a drug marketed by Mt Adams and is included in two NDAs. Additional details are available on the ISOPTIN profile page.

The generic ingredient in ISOPTIN is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.
Summary for 018485
Tradename:ISOPTIN
Applicant:Mt Adams
Ingredient:verapamil hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018485

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Chubb

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